Biocon Biologics Gains Approval for Bmab 1200 Biosimilar in Europe, UK, Canada, and Japan

Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd., has announced a significant settlement and license agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson. This agreement allows BBL to commercialize its biosimilar candidate Bmab 1200, an alternative to Stelara®, in Europe, the United Kingdom, Canada, and Japan.

The settlement resolves ongoing patent disputes, clearing the pathway for Bmab 1200's market entry in these regions. Regulatory filings for Bmab 1200 are currently undergoing review in these markets. Earlier, Biocon Biologics had reached a settlement in the United States, aiming for a market launch of Bmab 1200 no later than February 22, 2025, pending approval from the U.S. FDA. The FDA has already accepted the Company’s Biologics License Application (BLA) for Bmab 1200 under the 351(k) pathway.

Shreehas Tambe, CEO and Managing Director of Biocon Biologics Ltd, expressed that this settlement underscores the company's commitment to science and innovation. He emphasized that Bmab 1200 would enhance Biocon’s immunology portfolio, providing an accessible and effective treatment for autoimmune diseases.

Stelara® (Ustekinumab) is a monoclonal antibody effective against immune diseases tied to interleukin IL-12/23 regulation. It is approved for treating conditions such as psoriasis, Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. In 2023, Stelara® generated global sales of $10.85 billion.

Biocon Biologics Ltd, a subsidiary of Biocon Limited, is a global leader in biosimilars. The company aims to transform healthcare by making high-quality biosimilars accessible worldwide. They operate in over 120 countries, leveraging advanced science, innovative technology, and global manufacturing capabilities to reduce the cost of biological therapeutics while enhancing healthcare outcomes.

Biocon Biologics has already commercialized eight biosimilars in both emerging and advanced markets, including the U.S., Europe, Australia, Canada, and Japan. The company is developing a pipeline of 12 biosimilar assets spanning areas like diabetology, oncology, immunology, and ophthalmology. The company is committed to achieving several UN Sustainable Development Goals (SDGs) as part of its environmental, social, and governance (ESG) initiatives.

Biocon Limited, publicly listed since 2004, focuses on enhancing access to complex therapies for chronic conditions such as diabetes, cancer, and autoimmune diseases. The company has successfully developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and key global markets. Additionally, Biocon is working on a promising pipeline of novel immunotherapy assets.

In summary, the settlement and license agreement with Janssen marks a critical milestone for Biocon Biologics in its mission to bring affordable biosimilars to global markets. With regulatory reviews underway and a U.S. FDA decision pending, Bmab 1200 is poised to provide a cost-effective alternative for treating various autoimmune diseases, further establishing Biocon Biologics as a leader in the biosimilars industry.

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